Category Archives: Events

09Apr/18
Living-heart-project

Simulation for Product, Nature and Life

With 3D Printing and Virtual Human Modeling and Simulation, Life Science companies have the opportunity to innovate faster and with more confidence than ever before

By: Sandra K. Rodriguez, Market Analyst

SIMULIA is one of eleven brands at Dassault Systèmes.  During their Analyst Day, company executives provided an overview of the brand’s simulation offerings under a common theme: Enabling end-to-end digital design to production processes by deploying all multiphysics simulation technologies to enable clients to start making parts and systems that work, faster.

Print to Perform

3D Printing, also referred to as Additive Manufacturing (AM) is a complex process. However, on the 3DEXPERIENCE platform, users can digitally accelerate AM while creating lightweight, yet functional generative designs.  When moving from powder to working parts, there are significant challenges in the real-world process phase of AM. Using simulation for build planning, virtual printing, post-processing and heat treatment effects can optimize the build and ultimately save time by reducing errors and rework. With virtual printing, users can simulate not just a printing process but post-processing procedures and conduct in-service validation. Rather than relying on static documents and experience from expensive physical builds, establishing a digital thread from design to field performance unites all functionality and eliminates silos via a digital platform.  SIMULIA’s Additive Manufacturing message is clear: Print to Perform.

Virtual Human Modeling

Karl D’Souza, Sr. Solution Consultant, SIMULIA Virtual Human Modeling at Dassault Systèmes, pointed out that simulation is widespread in the development of medical devices but that a lot more is possible. In particular, medical device companies are now creating more realistic models of the human body to understand how a product will perform in its intended environment.  Continue reading

06Mar/18
MDIC_Logo_Tagline_3Color_webready

CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What’s In It For You?

By: Sandra K. Rodriguez, Market Analyst

On February 27th, the Medical Device Innovation Consortium (MDIC) provided a quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.  The program aims to build a culture of quality across the entire organization while producing measurable results including:

  • Reduce defects/re-work
  • Reduce costs
  • Accelerate time to market
  • Increase customer satisfaction

The pilot was announced in the Federal Register on December 28, 2017.  During the recent webinar, Kimberly Kaplan of CMMI Institute reviewed how the pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations can measure their capability to produce high quality devices and improve patient safety.  To date, 13 organizations have enrolled in the pilot program.  She pointed out early indications show industry is having a hard time shifting from an inspection or audit mindset, to an appraisal approach – which is more conversational in nature. Continue reading

18Jan/18
woman with fitbit

How the Internet of Medical Things (IoMT) Supports Improved Patient Outcomes

Webinar Recording Available On-Demand

By: Sandra K. Rodriguez, Market Analyst, Axendia

The Internet of Medical Things (IoMT) and the transition to outcomes based reimbursements are changing the way medical device companies approach new product development. IoMT and connected healthcare can enable the transition to patient-centered, preventative care.  IoMT connected devices are going to play an important role in supporting improved quality of care, patient outcomes, and also improving the business of healthcare in the outcome economy.  Yet with smart, connected products comes a new level of complexity throughout the total product lifecycle

In a recent FDANews webinar, I was joined by David Wolf and Jordan Reynolds, both Senior Managers with Kalypso.  We discussed the impact the increased number of connected IoMT devices is having on outcome based healthcare models, the potential benefits and pitfalls, and how to best leverage PLM solutions and IoT in a changing healthcare environment. Continue reading

11Jan/18
2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as:

11Dec/17
Moped

Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

Continue reading